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FDA 510(k)

BONDING RESIN PRODUCT LINE

K-Number: K931870 · 1993-07-22

ApplicantUltradent Products, Inc.
Decision Date1993-07-22
Product CodeKLE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

BONDING RESIN PRODUCT LINE is the device name listed in this FDA 510(k) record. The listed applicant is Ultradent Products, Inc.. It received FDA 510(k) clearance on 1993-07-22 under 510(k) number K931870. The device is classified under product code KLE. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BONDING RESIN PRODUCT LINE?

BONDING RESIN PRODUCT LINE is a medical device that received FDA 510(k) clearance on 1993-07-22. The listed applicant is Ultradent Products, Inc.. The 510(k) number is K931870.

When did BONDING RESIN PRODUCT LINE receive FDA 510(k) clearance?

BONDING RESIN PRODUCT LINE received FDA 510(k) clearance on 1993-07-22, under 510(k) number K931870.

Who is the listed applicant for BONDING RESIN PRODUCT LINE?

The FDA 510(k) record lists Ultradent Products, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BONDING RESIN PRODUCT LINE?

The FDA product code for BONDING RESIN PRODUCT LINE is KLE.

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Other records listing Ultradent Products, Inc. as applicant

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Related Devices (Code: KLE)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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